FDA warns GLP-1 Solution over compounded retatrutide and misleading claims
The letter says compounded retatrutide has no FDA-approved application behind it and did not meet the conditions that let some compounded drugs skip approval.
FDA's Center for Drug Evaluation and Research issued a warning letter dated September 9, 2025 to GLP-1 Solution, an online seller, over compounded retatrutide sold through its website [1]. Regulators called those products unapproved new drugs and misbranded drugs, and separately flagged two marketing claims about compounded semaglutide and tirzepatide as false or misleading [1].
The letter says FDA reviewed content on glp1solution.store in August 2025, when the site was offering compounded retatrutide, semaglutide and tirzepatide [1]. It was addressed to the company at an office address in Berlin, Germany, and sent by electronic mail [1].
For retatrutide, the agency's finding rests on compounding rules. Compounded drugs can qualify for exemptions from certain FDA requirements only if conditions in sections 503A or 503B of the federal Food, Drug, and Cosmetic Act are met, the letter explains [1]. Retatrutide clears neither set, according to the agency. The substance has no applicable United States Pharmacopeia or National Formulary monograph, is not a component of an FDA-approved human drug, and does not appear on the 503A bulk drug substances list [1]. Nor is it on the 503B list, and it is not being used to compound a product that appears on the FDA drug shortage list [1]. The letter also says retatrutide fails to qualify for FDA's interim policies covering bulk substances still under evaluation [1].
Because those exemptions do not apply, the products are not shielded from the requirement that a new drug have an FDA-approved application, or from the labeling rule that directions for use be adequate [1]. The letter states there are no approved applications on file for the retatrutide items [1]. It also says their intended uses are not ones a layperson can diagnose and treat on their own, so adequate directions cannot be written, making the labeling misbranded under section 502(f)(1) [1]. The sections cited for retatrutide are 505(a), 502(f)(1), 301(a) and 301(d) [1].
On the marketing side, FDA quoted two items it said appear on the website: the single word "MOUNJARO," and a sentence reading "Semaglutide is the generic drug delivered in Ozempic (injectable) and Rybelsus (oral) diabetes control medications, and Wegovy (injectable) weight loss medication" [1]. The agency's stated problem is that compounded drugs are not FDA-approved, so wording implying that a compounded item is the same as an approved product is false or misleading [1]. Those claims misbrand a compounded drug under sections 502(a) and 502(bb), the letter says, and shipping such products violates section 301(a) [1].
Why it matters for patients
The letter draws a line the agency says some sellers blur: an FDA-approved medicine, such as Ozempic, Wegovy, Rybelsus, Mounjaro or Zepbound, has an approved application behind it, while the compounded items named in this warning do not [1]. Retatrutide is not a component of any FDA-approved drug, according to the letter, so there is no approved version of it to compare against [1].
Compounded drugs are prepared by pharmacies or by registered outsourcing facilities rather than by the maker of a brand-name medicine. FDA's objection here concerns approval status and promotional language, not a finding about any particular batch. The letter does not describe an illness, injury or recall connected to the products [1], and it does not list ingredients, strengths or test results for them [1].
The document is a published enforcement letter. It states the agency's position and says the claims identified put the company on notice of FDA's concerns [1].
What happens next
The letter is dated September 9, 2025 [1]. Whether GLP-1 Solution has replied, stopped selling the products described, or revised the website language has not been disclosed [1]. The letter does not lay out a further enforcement step [1]. Whether retatrutide will be reviewed or approved by FDA for any use has not been reported [1].
Sources
Semaglutides.org provides information only, not medical advice. Talk to a licensed provider about your own care before making changes. Some telehealth links are affiliate links and are labeled where they appear.